Director, Statistics

The Director Medical Affairs & Health Technology Assessment (MA&HTA) Statistics leads and directs statistical strategies for one or more assigned therapeutic this visible and highly collaborative role the Director partners with Medical Affairs Market Access & Pricing and other key stakeholders to provide scientific and statistical expertise for drug development and life-cycle management strategies including the review design analysis and reporting of clinical or other scientific research programs. The Director leads generation of scientific evidence to support medical affairs and reimbursement strategies; engages with health technology assessment (HTA) bodies medical community and key opinion leaders (KOLs) to communicate outcomes; and evaluates and implements innovative study design and analytic methodologies for real world evidence (RWE) gathering analysis and interpretation.

Responsibilities:

• Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design analysis and reporting of clinical and other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with health authorities medical community and key opinion leaders (KOLs) regarding the results of these activities.

• Demonstrate an excellent understanding of statistical concepts and methodologies. Take a leadership role in introducing new/novel study design and/or statistical methodological approaches into study protocol and/or analysis plans which improve the efficiency and validity of study results. Be able to explain statistical concepts to non-statistician.
• Review identified or anticipated technical or data related issues arising in the design conduct or analysis of clinical trials or other scientific research. Select and supervise the evaluation of alternative analysis strategies or other recommendations to address these issues. Evaluate appropriateness of available software for planned analyses and assess needs for potential program development of novel statistical methodology.
• Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings. Present own statistical research or review of the statistical literature at meetings and seminars. Demonstrate a high degree of responsibility in maintaining Statistics department standards GxP compliance and best operating practice.

• In collaboration with Medical Affairs Clinical Statistics Data Sciences Statistical Programming Market Access and other stakeholders direct the assessment and evaluation of existing databases both clinical studies and real-world databases supervise the conduct of feasibility assessment to identify fit-for-purpose data sources for research questions and supervise the development of detailed and actionable analysis plans for evidence generation to deliver high quality patient-centric evidence and insights to drive decisions and scientific publications.
• Propose and direct evaluation of alternatives to traditional randomized clinical trials that make use of real-world databases e.g. electronic health records insurance claims databases and/or registries to fill critical evidence gaps.

• Represent function/department in cross-functional team(s) and ensure that study results and conclusions are scientifically sound clearly presented and consistent with the statistical analyses provided. Ensure timely and quality statistical deliverables. Represent MA&HTA Statistics in addressing questions at management and/or product review meetings. Provide in-depth scientific/statistical review for study protocol scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.

• Lead MA&HTA Statistics group in partnership with Medical Affairs Clinical Research Market Access and Clinical Statistics to develop scientifically appropriate strategies for evidence generation including real-world studies presentations and publications in assigned therapeutic area(s). Lead MA&HTA Statistics to provide functional area input for life cycle management of products.  Lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationship and collaboration.
• Train and mentor staff on statistical methodology and operations. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.

Qualifications :

• MS (with 12 years of experience) or PhD (with 8 years of experience) in Statistics Biostatistics or a highly related field.
• Demonstrate a high level of technical competence coupled with excellent oral and written communication skills.
• Skilled in designing both interventional and non-interventional studies. Proficient in descriptive and inferential statistics statistical modeling and programming. Expertise in methodologies for confounding control and bias minimization in observational studies is highly desirable.
• Capable of identifying data or analytical issues and providing solutions through personal expertise or by seeking assistance from others.
• A proven track record in supporting Medical Affairs and Health Technology Assessment (HTA) activities is highly desired.
• Able to build strong relationships with peers and cross-functional partners to achieve higher performance.
• Highly motivated to drive innovation by raising the bar and challenging the status quo.
• Open to learning new knowledge and technology and eager to adapt and improve. Enthusiastic about innovation with a self-starter attitude to turn possibilities into reality.
• Possess strong leadership skills and experience in working/managing cross-cultural or oversea teams.
• In-depth understanding of the pharmaceutical or related industries with experience in drug development and life-cycle management within a regulated environment.

Key Stakeholders

• Medical Affairs experts
• Clinical development experts
• Statistical programmers
• Data science experts
• Reimbursement Health Authority experts

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time